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临床试验/NCT06320002
NCT06320002已完成不适用

Improving Biopsychosocial Outcomes With a Communication Intervention for Patients Undergoing Fecal Ostomy Surgery

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Intervention Acceptability

研究概览

简要总结

In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.

详细描述

In this study the investigators are trying to understand the feasibility and acceptability of a psychologically informed communication guide for fecal ostomy Surgery with the overall goal of improving biopsychosocial outcomes of patients undergoing fecal ostomy surgery.

An estimated 100,000 people in the US undergo fecal ostomy surgery (colostomy or ileostomy) each year, frequently to address severe symptoms (i.e., obstruction, perforation, and incontinence) due to colorectal cancer, diverticulitis, and pelvic floor dysfunction. Complication rates after fecal ostomy surgery are high (up to 37%) with negative effects on patient and family quality of life. Surgeons do not traditionally identify and address health outcomes patients with serious illness prioritize when making treatment decisions, such as caregiver burden, loss of independence and psychosocial function. Communicating this information is key to address patient anxiety when facing major surgery and ensure caregiver preparedness among patients and families considering fecal ostomy surgery.

Current surgical guidelines support the use of preoperative communication and education interventions to improve psychosocial adjustment after fecal ostomy surgery based on expert opinion. However, little evidence exists evaluating the impact of communication interventions or content needs of patients undergoing fecal ostomy surgery or their family. Despite these guidelines, a recent study notes that inadequate ostomy education remains a frequent concern among patients undergoing fecal ostomy surgery. Furthermore, patients' perception of inadequate education is associated with poor emotional, social, and marital outcomes after surgery. There is a critical need to address this deficit in communication quality between patients undergoing fecal ostomy surgery, their family, and surgical care providers. Our guiding hypothesis is that development of a Communication Intervention for fecal ostomy Surgery (CI-oSurg) is acceptable to patients and clinicians, and will ultimately reduce patient distress and improve quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • English fluency and literacy
  • Patient planned to undergo elective fecal ostomy surgery

排除标准

  • Deemed inappropriate by the surgery team
  • Unable to provide consent due to severe cognitive impairment or physiologic status (septic shock/intubated)

研究组 & 干预措施

Fecal ostomy surgery participants receiving the CI-oSurg

Experimental

This arm will include patients who are undergoing or have undergone fecal ostomy surgery and surgical clinicians caring for the patients who will receive the CI-oSurg intervention.

干预措施: Communication Intervention for fecal ostomy surgery (Behavioral)

结局指标

主要结局

Intervention Acceptability

时间窗: 4 weeks after the intervention

The intervention acceptability will be assessed by cognitive interviews with participants

次要结局

  • Intervention Usability(4 weeks after intervention use)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christy E. Cauley, MD, MPH

Assistant Professor

Massachusetts General Hospital

研究点 (1)

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